K073711 · Ed. Geistlich Soehne AG Fuer Chemische Industrie · NPL · May 30, 2008 · Dental
Device Facts
Record ID
K073711
Device Name
MUCOGRAFT COLLAGEN MATRIX
Applicant
Ed. Geistlich Soehne AG Fuer Chemische Industrie
Product Code
NPL · Dental
Decision Date
May 30, 2008
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 872.3930
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
MUCOGRAFT® Collagen Matrix is recommended for: Simultaneous use of GBR-membrane (MUCOGRAFT) and implants; Covering of implants placed in immediate extraction sockets; Covering of implants placed in delayed extraction sockets; Localized ridge augmentation for later implantation; Alveolar ridge reconstruction for prosthetic treatment; Covering of bone defects after root resection, cystectomy, removal of retained teeth; Guided bone regeneration in dehiscence defects; and Guided tissue regeneration procedures in periodontal and recession defects.
Device Story
MUCOGRAFT® is a resorbable, bilayer collagen membrane derived from porcine peritoneum (smooth layer) and skin (porous layer). Used in dental surgery by clinicians to facilitate guided bone and tissue regeneration. The smooth, non-permeable outer layer acts as a barrier to prevent cell adhesion and protect the graft from oral trauma; the porous inner layer encourages cell invasion and stabilizes blood clots. The device is implanted at the surgical site to support healing and tissue growth. It is biodegradable and eliminates the need for secondary surgical removal. Benefits include improved handling, suturability, and promotion of bone/tissue regeneration in various dental defects.
Clinical Evidence
No clinical data provided. Substantial equivalence is based on bench testing, material characterization, and comparison to legally marketed predicate devices.
Technological Characteristics
Bilayer collagen membrane (Type I and III) from porcine source. Smooth layer (peritoneum) for barrier function; porous layer (skin) for cell infiltration. Sterilized via gamma irradiation. Dry thickness 2.5-5 mm; wet thickness ~1 mm. Non-crosslinked, non-chemically treated. Standalone implantable device.
Indications for Use
Indicated for dental patients requiring guided bone or tissue regeneration, including implant placement in extraction sockets, ridge augmentation, alveolar reconstruction, bone defect coverage (post-resection/cystectomy/tooth removal), and periodontal/recession defect repair.
Regulatory Classification
Identification
Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.
Special Controls
*Classification.* (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval.
(c)
*Date premarket approval application (PMA) or notice of product development protocol (PDP) is required.* Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
{0}------------------------------------------------
## 510(k) Summary
.
: .
:
:
## MUCOGRAFT®
MAY 3 0 2008
#### SPONSOR 1.
Ed. Geistlich Soehne Ag für Chemische Industrie Geistlich Pharma Ag-Bahnhofstrasse 40 CH-6110 Wolhusen SWITZERLAND
Contact Person: Peter S. Reichertz, (202) 772-5333 Date Prepared: May 22, 2008
#### 2. · DEVICE NAME
| Proprietary Name | MUCOGRAFT® Collagen Matrix |
|----------------------|------------------------------------------------------------------------|
| Common/Usual Name: | Resorbable Bilayer Membrane for Guided Tissue and Bone<br>Regeneration |
| Classification Name: | Barrier, Animal Source, Dental |
#### 3. PREDICATE DEVICES
MUCOGRAFT® (K012423 and K061244) BIO-GIDE® (K960724; K042197; and K050446)
#### 4. INTENDED USE
MUCOGRAFT® Collagen Matrix is recommended for:
- Simultaneous use of GBR-membrane (MUCOGRAFT) and implants; ー
- ﺴﺘ Covering of implants placed in immediate extraction sockets;
- -Covering of implants placed in delayed extraction sockets:
- ー Localized ridge augmentation for later implantation:
- -Alveolar ridge reconstruction for prosthetic treatment;
- -Covering of bone defects after root resection, cystectomy, removal of retained teeth;
- . Guided bone regeneration in dehiscence defects; and
- Guided tissue regeneration procedures in periodontal and recession defects. -
i
{1}------------------------------------------------
#### DEVICE DESCRIPTION 5.
MUCOGRAFT® is a pure collagen membrane obtained by a standardized controlled manufacturing process. The membrane is made of collagen type I and type III without further cross-linking or chemical treatment. The collagen is extracted from veterinary certified pigs and is carefully purified to avoid antigenic reactions. MUCOGRAFT® is sterilized in double blisters by gamma irradiation. MUCOGRAFT® has a bilayer structure with one smooth, non-permeable layer and one porous. The "outer," smooth side has a smooth surface which is cell occlusive and prevents cell adhesion and acts as a barrier. It allows tissue adherence favoring wound healing. It is made from the peritoneum of pigs. This side is turned towards the soft tissue. The smooth texture has appropriate elastic properties to accommodate suturing to the host mucosal margins and to protect the graft material from oral trauma during biodegradation and healing. The "inner" porous layer consists of collagen fibers in a loose, porous arrangement to enable cell invasion. This porous layer is made from pig skin. This side is turned toward the bone defect and/or soft tissue to encourage bone-forming cells and tissue growth and to stabilize the blood clot.
#### 6. BASIS FOR SUBSTANTIAL EQUIVALENCE
MUCOGRAFT® collagen matrix is substantially equivalent to Geistlich's existing products MUCOGRAFT® resorbable bilayer membrane (K012423 and K061244) and BIO-GIDE® resorbable bilayer membrane for guided tissue and bone regeneration (subject to K960724; K042197; and K050446). The differences between the new product and the BIO-GIDE and MUCOGRAFT® products cleared previously via K061244 and K042197, respectively, are the following: (1) changes to the manufacturing process, including a change in the concentration and duration of the alkaline treatment step, a new freeze-dryer, and the solvent cleaning phase being performed earlier in the process; (2) a change in the blister material from polystyrene (PS) to amorphic polyethylene terephtalate (A-PET); (3) changes to the product specifications, including a parametric release for the Gamma-Sterilization, and the omission of certain release controls; (4) expanded indication for use in Guided Tissue Regeneration; (5) a new-layout for the product label and packaging; and (6) the thickness of membrane when dry is 2.5 mm to 5 mm as opposed to 2 mm with MUCOGRAFT® Resorbable Bilayer Membrane, but when wet and placed into a defect, both are approximate 1 mm. The proposed additional indication is for "guided tissue regeneration procedures in periodontal defects." Included by reference are all data submitted in the previous notification and clearance of BIO-GIDE® (K042197) and MUCOGRAFT® Resorbable Bilayer Membrane (K061244).
MUCOGRAFT®, like BIO-GIDE®, is a collagen membrane used in dental grafting, procedures. MUCOGRAFT® was previously determined to be substantially equivalent to BIO-GIDE® and is cleared for all of the indications for which BIO-GIDE® is cleared.
The following is a table comparing MUCOGRAFT® Collagen Matrix to MUCOGRAFT® Resorbable Bilayer Membrane for guided tissue and bone regeneration.
{2}------------------------------------------------
## Table 1: MUCOGRAFT® Resorbable Bilayer Membrane (Predicate Device) vs. MUCOGRAFT® Collagen Matrix Comparison Chart
| | MUCOGRAFT® Resorbable<br>Bilayer Membrane | MUCOGRAFT®<br>Collagen Matrix |
|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Used for guided tissue<br>regeneration procedures in<br>periodontal defects to enhance<br>regeneration of the periodontal<br>apparatus. | Used for guided tissue<br>regeneration procedures in<br>periodontal defects to enhance<br>regeneration of the periodontal<br>apparatus. |
| Incorporates Same Basic Design | Yes | Yes |
| Utilizes Same Operating Principle | Cell occlusive<br>Implantable<br>Resorbable<br>Hemostatic | Cell occlusive<br>Implantable<br>Resorbable<br>Hemostatic |
| Incorporates Same Materials? | Yes, Type I and Type III<br>Collagen<br>Same Amount | Yes, Type I and Type III<br>Collagen<br>Same Amount |
| Sterilization Process | Gamma Irradiation | Gamma Irradiation |
| Biocompatible | Yes | Yes |
| Non-pyrogenic | Yes | Yes |
| Shelf Life | 36 Months | 36 Months |
| Thickness (dry) | Approx. 2 mm | Approx. 2.5-5 mm |
| Thickness (when placed over<br>defect) | Approx. 1 mm | Approx. 1 mm |
W02-EAST:9DMS1\200050430.1
and the comments of the comments of
:
:
:
.
and the comments of the comments of
- - - - - - -1. 1. 1. 1.
{3}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, facing left. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Public Health Service
MAY 3 0 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ed. Geistlich Soehne Ag Für Chemische Industrie C/O Mr. Peter S. Reichertz Sheppard, Mullin, Richter & Hampton LLP 1300 I Strect, N.W., 11th Floor East Washington, DC 20005
Re: K073711
Trade/Device Name: MUCOGRAFT® Collagen Matrix Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: NPL Dated: May 22, 2008 Received: May 23, 2008
Dear Mr. Reichertz:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
{4}------------------------------------------------
Page 2 -- Mr. Reichertz
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
{5}------------------------------------------------
# K073711
## Indications for Use
### 510(k) Number (if known): K073711
Device Name:
MUCOGRAFT® Collagen Matrix.
Indications for Use:
Simultaneous use of GBR-membrane (MUCOGRAFT®) and implants; covering of implants placed in immediate extraction sockets; covering of implants placed in delayed extraction sockets; localized ridge augmentation for later implantation; alveolar ridge reconstruction for prosthetic treatment; covering of bone defects after root resection; cystectomy, removal of retained teeth; guided bone regeneration in dehiscence defects; guided tissue regeneration procedures in periodontal and recession defects.
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X (Part 21 CFR 801 Subpart D) OR
Over-the-Counter Use (21 CFR 801 Subpart C)
Susan Runore
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number.
K073711
W02-EAST:9EJJ1\200052247.1
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
